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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Insufflator, Hysteroscopic
510(k) Number K922632
Device Name WOM HYSTEROFLATOR OP
Applicant
W.O.M. GmbH
Pascalstrabe 11
Berlin,  DE D-10587
Applicant Contact OWEN LAMB
Correspondent
W.O.M. GmbH
Pascalstrabe 11
Berlin,  DE D-10587
Correspondent Contact OWEN LAMB
Regulation Number884.1700
Classification Product Code
HIG  
Date Received03/04/1992
Decision Date 03/25/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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